MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW; 2.0X5MM SUS PUSH SCR 2/PK

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

The user facility reported a 915-2336 screw broke during surgery which resulted in a 45 minute delay.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Manufacturer Narrative

The product was expected to be returned for evaluation, however the customer has been contacted multiple times and no response or the product have been received.Without a product return, no product evaluation is able to be conducted.Review of device history records show that lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Fields were updated.

• Brand Name: LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
• Type of Device: 2.0X5MM SUS PUSH SCR 2/PK
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle coldwater ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4268632
• MDR Text Key: 5226760
• Report Number: 0001032347-2014-00397
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK013557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 915-2336
• Device Lot Number: 642640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization